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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceXIENCE V/nano Everolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd., Bldg. G
P.O. Box 9018
Temecula, CA 92589
PMA NumberP070015
Supplement NumberS139
Date Received12/11/2017
Decision Date03/05/2018
Withdrawal Date04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternate contract sterilizer site located at Synergy Heath Ireland Ltd, IDA Business & Technology Park, Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland. To perform as an alternate ethylene oxide sterilization vendor for the GRAFTMASTER Coronary Stent Graft System, MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System, XIENCE V and Nano Everolimus Eluting Coronary Stent System, and XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL).
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